Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users (TEXTR34)

Many drug users living with HIV demonstrate inadequate levels of medication adherence, and are at high risk for disengaging from care. HIV positive drug users are at even higher risk of poor medication adherence and treatment dropout when living far from treatment centers. Rural residence is common in the U.S. South where rates of new HIV infections are disproportionately high, especially among ethnic minorities. While there are efficacious interventions to improve HIV treatment adherence, only a few have targeted drug users, and these have required patients to come into research clinics for adherence interventions. Transportation problems, poverty, isolation, and stigma are known barriers to accessing adherence support among rural drug users with HIV.Additionally, most adherence interventions aim to increase adherence, but come too late, unable to respond in real time to adherence lapses to help patients re-initiate appropriate medication use while remaining in their natural environments. There is a pressing need to develop tailored, scalable interventions that detect nonadherence episodes in real time and enhance adherence to HIV treatment immediately. Building interventions upon familiar, existing technology could extend their reach into communities of non-urban patients living with HIV, overcoming common barriers to care, and could ultimately be scaled up to help drug using HIV+ patients nationwide.

The investigators propose to develop and test the feasibility and promise of a combined HIV adherence assessment and intervention application for rural drug users using an available, familiar technology whose reach will grow exponentially: text messaging via mobile phones. By 2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration projected by 2013. While technology adoption is often slower in under-served communities, the trend is different with mobile phone technology. African-Americans are using more mobile phone minutes per capita and increasing their use at a higher rate compared with other ethnic groups. This technology has great potential to reduce health disparities. In this project, the investigators will develop and test the feasibility and promise of a text messaging application and system using Ecological Momentary Assessment methods to detect nonadherence and drug use and immediately intervene to improve HIV treatment adherence in drug users living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a project in the Stage Model of Behavioral Therapy Development that will develop novel interventions and methods, and generate preliminary estimates of effect sizes that will determine whether a larger clinical trial with extended follow-up and cost-effectiveness evaluation is warranted.

The specific aims of this project are:

1. To identify assessment and intervention features relevant to the adherence barriers and drug use patterns of rural and non-urban HIV+ drug users using formative methods including:

   • structured interviews and focus groups to identify specific barriers to adherence and engagement in care and needs related to drug craving and drug use that should be addressed by the intervention
   • iterative usability testing of components and drafts of the intervention

2. To create a text messaging mobile phone application and system (Treatment Extension by Texting, Text) to assess and improve HIV treatment adherence and drug use in real time

   --Text will be built upon a piloted unidirectional personalized text phone application and system, STeM, and will include pre- and post-programming usability testing

3. To test the feasibility and promise of the assessment and intervention tool in a randomized pilot trial of rural HIV+ drug users with detectable viral load (VL) comparing Text to usual care

   • Feasibility: Identify recruitment rates, consent rates, participant flow, completion rates, and variance of key covariates and outcome variables
   • Promise: determine point estimates and the precision of effects for primary and secondary adherence outcomes including pharmacy refills and unannounced pill counts (medication adherence), missed visit percentage (treatment engagement), VL, and drug craving and drug use.